Trial Outcomes & Findings for Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer (NCT NCT05653856)
NCT ID: NCT05653856
Last Updated: 2025-01-24
Results Overview
To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.
COMPLETED
PHASE2
26 participants
4 Hours
2025-01-24
Participant Flow
The study was conducted in 9 sites across USA, Recruitment was initiated on 30 November, 2022 and was closed on 17 May 2023.
Participant milestones
| Measure |
Diagnostic Imaging With 64Cu-PSMA-I&T
64Cu-PSMA I\&T: Radiolabeled Receptor-Targeted Diagnostic Product
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic Imaging With 64Cu-PSMA-I&T
n=26 Participants
64Cu-PSMA I\&T: Radiolabeled Receptor-Targeted Diagnostic Product
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=99 Participants
|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 7.73 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Height
|
176.0 CM
STANDARD_DEVIATION 6.45 • n=99 Participants
|
|
Weight
|
91.3 KG
STANDARD_DEVIATION 15.87 • n=99 Participants
|
|
Body Mass Index (BMI)
|
29.43 kg/m^2
STANDARD_DEVIATION 4.544 • n=99 Participants
|
PRIMARY outcome
Timeframe: 4 HoursPopulation: The PET/CT images were acquired for all 26 patients at 1 hour and 4 hours post copper Cu 64 PSMA I\&T injection and interpreted independently by 3 readers blinded to clinical information and findings on the composite reference standard.
To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.
Outcome measures
| Measure |
Diagnostic Imaging With 64Cu-PSMA-I&T
n=26 Participants
64Cu-PSMA I\&T: Radiolabeled Receptor-Targeted Diagnostic Product
|
|---|---|
|
Region-Level Correct Localization Rate (CLR)
Reader 1 (1-Hour Image)
|
86.67 percentage of Regions
Interval 69.28 to 96.24
|
|
Region-Level Correct Localization Rate (CLR)
Reader 1 (4-Hour Image)
|
86.67 percentage of Regions
Interval 69.28 to 96.24
|
|
Region-Level Correct Localization Rate (CLR)
Reader 2 (1-Hour Image)
|
76.67 percentage of Regions
Interval 57.72 to 90.07
|
|
Region-Level Correct Localization Rate (CLR)
Reader 2 (4-Hour Image)
|
80.00 percentage of Regions
Interval 61.43 to 92.29
|
|
Region-Level Correct Localization Rate (CLR)
Reader 3 (1-Hour Image)
|
80.00 percentage of Regions
Interval 61.43 to 92.29
|
|
Region-Level Correct Localization Rate (CLR)
Reader 3 (4-Hour Image)
|
80.00 percentage of Regions
Interval 61.43 to 92.29
|
PRIMARY outcome
Timeframe: 4 HoursPopulation: The PET/CT images were acquired for all 26 patients at 1 hour and 4 hours post copper Cu 64 PSMA I\&T injection and interpreted independently by 3 readers blinded to clinical information and findings on the composite reference standard.
To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.
Outcome measures
| Measure |
Diagnostic Imaging With 64Cu-PSMA-I&T
n=26 Participants
64Cu-PSMA I\&T: Radiolabeled Receptor-Targeted Diagnostic Product
|
|---|---|
|
Patient-Level Correct Detection Rate (CDR)
Reader 1 (1-Hour Image)
|
84.21 percentage of Patients
Interval 68.04 to 100.0
|
|
Patient-Level Correct Detection Rate (CDR)
Reader 1 (4-Hour Image)
|
84.21 percentage of Patients
Interval 68.04 to 100.0
|
|
Patient-Level Correct Detection Rate (CDR)
Reader 2 (1-Hour Image)
|
77.19 percentage of Patients
Interval 58.79 to 95.59
|
|
Patient-Level Correct Detection Rate (CDR)
Reader 2 (4-Hour Image)
|
79.82 percentage of Patients
Interval 61.55 to 98.1
|
|
Patient-Level Correct Detection Rate (CDR)
Reader 3 (1-Hour Image)
|
80.70 percentage of Patients
Interval 63.71 to 97.69
|
|
Patient-Level Correct Detection Rate (CDR)
Reader 3 (4-Hour Image)
|
80.70 percentage of Patients
Interval 63.71 to 97.69
|
PRIMARY outcome
Timeframe: 24 HoursPopulation: All 26 patients were analyzed for Adverse Events through the monitoring of clinical and laboratory safety parameters.
Adverse events (AEs) were assessed from the time of copper Cu 64 PSMA I\&T injection throughout the24-hour assessment period. AEs were assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Diagnostic Imaging With 64Cu-PSMA-I&T
n=26 Participants
64Cu-PSMA I\&T: Radiolabeled Receptor-Targeted Diagnostic Product
|
|---|---|
|
Incidence of Adverse Events
Adverse Events (AEs)
|
3 Participants
|
|
Incidence of Adverse Events
Serious Adverse Events (SAEs)
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 HoursPopulation: The PET/CT images were acquired for all 26 patients at 1 hour and 4 hours post copper Cu 64 PSMA I\&T injection and interpreted independently by 3 readers blinded to clinical information and findings on the composite reference standard.
To compare the diagnostic quality of PET/CT images obtained at 1 hour and 4 hours post copper Cu 64 PSMA I\&T injection. Image quality score is based on a scale of 0-2 where 0 is not of diagnostic quality and 2 is of best diagnostic quality.
Outcome measures
| Measure |
Diagnostic Imaging With 64Cu-PSMA-I&T
n=26 Participants
64Cu-PSMA I\&T: Radiolabeled Receptor-Targeted Diagnostic Product
|
|---|---|
|
Score of Image Quality
Reader 1 (1-Hour Post Dose) · Inadequate
|
0 Participants
|
|
Score of Image Quality
Reader 1 (1-Hour Post Dose) · Questionable
|
0 Participants
|
|
Score of Image Quality
Reader 1 (1-Hour Post Dose) · Acceptable
|
26 Participants
|
|
Score of Image Quality
Reader 1 (4-Hour Post Dose) · Inadequate
|
0 Participants
|
|
Score of Image Quality
Reader 1 (4-Hour Post Dose) · Questionable
|
0 Participants
|
|
Score of Image Quality
Reader 1 (4-Hour Post Dose) · Acceptable
|
26 Participants
|
|
Score of Image Quality
Reader 2 (1-Hour Post Dose) · Inadequate
|
0 Participants
|
|
Score of Image Quality
Reader 2 (1-Hour Post Dose) · Questionable
|
2 Participants
|
|
Score of Image Quality
Reader 2 (1-Hour Post Dose) · Acceptable
|
24 Participants
|
|
Score of Image Quality
Reader 2 (4-Hour Post Dose) · Inadequate
|
0 Participants
|
|
Score of Image Quality
Reader 2 (4-Hour Post Dose) · Questionable
|
0 Participants
|
|
Score of Image Quality
Reader 2 (4-Hour Post Dose) · Acceptable
|
26 Participants
|
|
Score of Image Quality
Reader 3 (1-Hour Post Dose) · Inadequate
|
0 Participants
|
|
Score of Image Quality
Reader 3 (1-Hour Post Dose) · Questionable
|
0 Participants
|
|
Score of Image Quality
Reader 3 (1-Hour Post Dose) · Acceptable
|
26 Participants
|
|
Score of Image Quality
Reader 3 (4-Hour Post Dose) · Inadequate
|
0 Participants
|
|
Score of Image Quality
Reader 3 (4-Hour Post Dose) · Questionable
|
0 Participants
|
|
Score of Image Quality
Reader 3 (4-Hour Post Dose) · Acceptable
|
26 Participants
|
Adverse Events
Diagnostic Imaging With 64Cu-PSMA-I&T
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period no less than 90 days but less than or equal to 120 days from the time submitted to the sponsor for review. Also, the PI can utilize results of clinical tests and site and patient outcome information only for its own internal non-commercial teaching, research, patient care, and treatment and publication purposes.
- Publication restrictions are in place
Restriction type: OTHER